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Delivering MIDS Cardiac™ would allow the technology to be applied to multiple other immunoassay tests with a global market that’s projected to be worth $25.45 billion by 2021

The global point-of-care (POC) diagnostics market is forecast to grow at a CAGR of 10 percent, from $23.71 billion in 2017 to $38.13 billion in 2022, according to a recent Research and Markets report (http://nnw.fm/o0fNq). Zenosense, Inc. (OTC: ZENO) is well positioned to capitalize on the projected growth in this market through the development and commercialization of its MIDS Cardiac device, a game changing POC technology.

Through its joint venture ownership of MIDS Medical Limited (MML), development is being carried out at MML’s laboratories at the Sci-Tech Daresbury campus in the UK, a facility that’s internationally recognized for leading-edge scientific research and commercial development. MML has exclusive rights to the MIDS technology platform, protected by patents granted in the U.S. and China and patent applications in other countries around the world.

MIDS Cardiac is being developed as a cost-effective handheld device reading a disposable blood test strip to conduct high sensitivity cardiac diagnostic assays. The analytical sensitivity gap between central laboratory testing platforms and existing POC testing devices is significant. It has hindered the adoption of POC tests, even though they have a far quicker turnaround time. POC devices, like analyzers, generally rely on optical detection of commonly used paramagnetic assay beads. This bulky technology has not been successfully miniaturized into high sensitivity capable, hand-held devices.

MIDS’ key differentiator is its unique ability to detect and measure these assay beads by their total aggregated nano-magnetic signal, rather than conventional optical detection. Initial testing has demonstrated that this novel approach should enable MML to develop a highly sensitive, accurate, miniaturized device to support high-sensitivity cardiac biomarker testing. Such a POC device could be used in the emergency room, a doctor’s office, the bedside and by paramedics in emergency situations, such as in an ambulance.

A POC device for easy, accurate and rapid testing of very low levels of cardiac biomarkers is a critical unmet medical need. Currently, troponin is the preferred biomarker for AMI. However, high sensitivity analysis can currently only be conducted by skilled operators using expensive equipment in central laboratories. This procedure typically requires at least a 60 minutes turnaround time, which is often way too long when time is critical. MIDS Cardiac is being developed to be the first POC device to be able to conduct truly high-sensitivity diagnostic assays, notably to identify and measure extremely low levels of cardiac biomarkers, particularly troponin, at the POC. This would significantly speed up triage, diagnosis and treatment of patients reporting chest pain symptoms that may be indicative of heart attack, allowing a far quicker rule-in or rule-out for AMI. The cost-effective MIDS Cardiac device is being designed for use at POC by minimally trained emergency professionals, with the ability to provide troponin results within three minutes and more extensive biomarker testing within eight minutes, from a pinprick of blood.

MML’s initial testing of the company’s ‘Hybrid Strip’ system was carried out in late 2017. The Hybrid Strip, for initial testing purposes, aims to replicate as far as possible the planned MIDS ‘Lab on Chip’ technology, which is expected to give a very high level of accuracy, equal to or better than laboratory analyzers.

MML’s initial test results show that a range of sizes of commercially available assay beads could be nano-magnetically detected in very low quantities. In a news release, managing director and chief scientific officer of MML Dr. Nasser Djennati said, “These results come in at the very high end of detection expectations, even at this Hybrid Strip stage. As we move forward into true Lab on Chip construction, I expect detection levels to improve further still.”

Every 43 seconds, someone in the U.S. has a heart attack, and every 60 seconds someone dies from a heart disease-related event. Zenosense has expressed confidence that MIDS Cardiac will provide a cost-effective, fast, accurate and reliable device for emergency diagnosis of AMI by medical professionals in low-resource settings.

The MIDS platform technology is also expected to have a far wider application beyond cardiac testing, for the cost-effective POC testing of numerous medical conditions. MML’s ultimate aim is to develop a multi-capability, hand-held device with laboratory analyzer ‘Gold Standard’ accuracy, for the diagnosis of conditions such as cancer, stroke, inflammatory/autoimmune disease, bacterial and viral infections and many more indications.

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